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A Phase 1b Study Evaluating RESTEN-MP in Subjects With Focal de Novo Stenosis

NCT00244647 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2008-04-10

No results posted yet for this study

Summary

The process of re-narrowing of a coronary artery following a revascularization procedure such as angioplasty, begins at the time of the procedure. Restenosis has long been considered a major problem for effective long-term interventional success. This often results in repeated procedures to deal with recurrent stenosis (or restenosis) of the original targeted vessel.

There is a substantial body of literature suggesting that local MYC protein production in the injured coronary artery is a major stimulus and potential cause of restenosis that appears after stent placement. This study is based upon the hypothesis that stopping MYC protein production in the vessel has will help reduce restenosis (vessel re-narrowing).

AVI BioPharma Inc., has utilized its proprietary antisense chemistry to design a drug that interferes with MYC production.

This study will evaluate the safety, pharmacokinetics and potential effectiveness of a single intravenous slow-push dose of RESTEN-MP at the time of stent placement to reduce in-stent restenosis following balloon angioplasty and stent placement. The post-dose follow-up period is up to six-months.

Conditions

Interventions

DRUG

RESTEN-MP

Sponsors & Collaborators

  • Sarepta Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Thomas Porter, M.D. · University of Nebraska

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-08-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00244647 on ClinicalTrials.gov